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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K071948
Device Name AEQUALIS REVERSED ADAPTER
Applicant
Tornier
161 Rue Lavoisier
Montbonnot
Saint-Ismier Cedex,  FR 38334
Applicant Contact Mireille Lemery
Correspondent
Tornier
161 Rue Lavoisier
Montbonnot
Saint-Ismier Cedex,  FR 38334
Correspondent Contact Mireille Lemery
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received07/13/2007
Decision Date 10/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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